WHA
 

Vyndaqel (tafamidis meglumine), Vyndamax (tafamidis)

Indications for Prior Authorization

Vyndaqel (tafamidis meglumine), Vyndamax (tafamidis)
  • For diagnosis of Transthyretin-mediated amyloidosis with cardiomyopathy (ATTR-CM)
    Indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.

Criteria

Vyndaqel, Vyndamax

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

  • Diagnosis of transthyretin-mediated amyloidosis with cardiomyopathy (ATTR-CM)
    • AND
  • One of the following: [3-5]
    • Presence of a transthyretin (TTR) mutation (e.g., V122I) as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
      • OR
    • Cardiac or noncardiac tissue biopsy demonstrating histologic confirmation of TTR amyloid deposits
      • OR
    • Both of the following:
      • Nuclear scintigraphy scan positive for cardiac transthyretin (ATTR) amyloidosis (defined as Perugini Grade 2 or 3 uptake)
      • Absence of light-chain (AL) amyloidosis (confirmed by negative monoclonal protein testing including serum free light chain assay, serum immunofixation, and urine immunofixation)
    AND
  • Patient has New York Heart Association (NYHA) Functional Class I, II, or III heart failure [2]
    • AND
  • Requested drug is not used in combination with a TTR silencer (e.g., Amvuttra) or a TTR stabilizer (e.g., Diflunisal)
    • AND
  • Prescribed by or in consultation with a cardiologist
Vyndaqel, Vyndamax

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

  • Patient continues to have New York Heart Association (NYHA) Functional Class I, II, or III heart failure
    • AND
  • Requested drug is not used in combination with a TTR silencer (e.g., Amvuttra) or a TTR stabilizer (e.g., Diflunisal)
    • AND
  • Prescribed by or in consultation with a cardiologist

  • Guideline ID
    GL-629192

  • Formulary
    premium

  • Effective date
    Aug 1, 2026

  • P&T approval date
    Jun 19, 2019

P & T Revisions

2026-06-18, 2025-06-20, 2025-02-20, 2024-08-14, 2024-06-20, 2023-12-20, 2023-10-17, 2023-05-08, 2022-05-22, 2021-06-22, 2021-05-26, 2021-05-25, 2020-06-22

  1. Vyndaqel and Vyndamax prescribing information. Pfizer, Inc. New York, NY. October 2023.
  2. Mauer MS, Schwartz JH, Gundapeneni B, et al. Tafamadis treatment for patients with transthyretin amyloid cardiomyopathy. N Engl J Med. 2018; 379:1007-16.
  3. Gillmore JD, Maurer MS, Falk RH, et al. Nonbiopsy diagnosis of cardiac transthyretin amyloidosis. Circulation. 2016; 133:2404-12.
  4. Nativi-Nicolau J and Maurer MS. Amyloidosis cardiomyopathy: update in the diagnosis and treatment of the most common types. Curr Opin Cardiol. 2018; 33(5):571-579.
  5. Kittleson MM, Ambardekar AV, Cheng RK, et al. Transthyretin Cardiac Amyloidosis Evaluation and Management: 2025 ACC Concise Clinical Guidance. J Am Coll Cardiol. 2026; 87:549‑565.
  • 2026-06-18: 2026 annual review: Updated criterion 2.3. Background updates.
  • 2025-06-20: 2025 annual review: Removed duplicated phrase "suggestive of amyloidosis" from criterion 2.3 with no changes to clinical intent.
  • 2025-02-20: Updated criterion 2.3 in line with Attruby along with standard ORx language throughout GL. Removal of requirement of evidence of HF criterion from initial auth and 'patient demonstrates positive clinical response to therapy' form reauth as per P&T recommendations.
  • 2024-08-14: Addition of criterion to confirm the requested drug is not used in combination with a TTR silencer or a TTR stabilizer.
  • 2024-06-20: 2024 annual review: no criteria changes.
  • 2023-12-20: Program update to standard reauthorization language. No changes to clinical intent.
  • 2023-10-17: Program update to standard reauthorization language. No changes to clinical intent.
  • 2023-05-08: 2023 UM Annual Review. No criteria changes. Update references
  • 2022-05-22: 2022 Annual Review
  • 2021-06-22: Updated references section.
  • 2021-05-26: Addition of EHB formulary to guideline, no changes to criteria
  • 2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
  • 2020-06-22: Updated references.